Transcatheter Aortic Valve Implantation For High Risk Patients With Severe Aortic Stenosis Using the Edwards Sapien Balloon-Expandable BioProsthesis: A Single Centre Study With Immediate and Medium-Term Outcomes

Background: Transcatheter aortic valve implantation (TCAVI) is an emerging alternative therapy to open-heart surgery in high-risk patients with symptomatic aortic stenosis. Methods: Between January 2007 and May 2009, 46 patients underwent TCAVI with the 23 mm or 26 mm Edwards Sapien bioprosthesis via either the transapical (TA-AVI) or transfemoral (TF-AVI) approach. All patients had an estimated operative mortality risk of >15%. Results: A total of 46 patients (30 TA-AVI, 16 TF-AVI) with a mean aortic valve area (AVA) of 0.63 +/- 0.2 cm(2) and mean gradient of 54 +/- 16 mm Hg were treated. Predicted operative mortality was 25.3% by logistic Euroscore and 8.7% by Society of Thoracic Surgeons risk score. Procedural success was 93% in the TA-AVI group and 88% in the TF-AVI group. There was one intraprocedural death in the TA-AVI group. Overall 30-day mortality was 6.5% (2-TA-AVI, 1-TF-AVI). Four patients (9.5%) died from noncardiac causes after 30 days. Successful TCAVI was associated with a significant increase in AVA from 0.6 +/- 0.1 cm(2) to 1.6 +/- 0.6 cm(2) in the TA-AVI group and 0.6 +/- 0.1 cm(2) to 1.4 +/- 0.2 cm(2) in the TF-AVI group at a mean follow up of 7.4 +/- 4.4 and 8.3 +/- 5.0 months, respectively. At discharge, there was significant improvement in AVA (P < 0.0001), transaortic mean gradient (P < 0.0001), and mitral regurgitation (P = 0.01). At medium term follow up, the valve area was maintained and there was significant improvement in NYHA class in both groups (P < 0.0001). Conclusion: At medium term follow-up, both transcatheter approaches demonstrated good valve durability with no cardiac-related mortality post hospital discharge. (C) 2009 Wiley-Liss, Inc.